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Remineralizing Efficacy of Grape Seed Extract in Management of White Spot Lesion in Post Orthodontic Treated Patients.

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Cairo University

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Abstract

This clinical trial will be conducted to compare the efficacy of grape seed extract oil versus sodium fluoride mouth wash in the management of remineralization in adult patients with white spot lesion over six months.

Description

Natural products have long been used in traditional medicine and are promising sources for novel therapeutic agents, especially in treating oral diseases such as dental caries.

Previously, herbs are used in dentistry for prevention and curative purpose of dental caries. The main advantages of using herbal alternatives are easy availability, cost effectiveness, increased shelf life, low toxicity, and lack of microbial resistance.

Grape seed extract (GSE) has been found to be a promising natural remineralizing agent for treatment of the demineralized tooth.

Grape seed extract (GSE), a readily available over the counter supplement, has been noted for its potential dental restorative and caries preventative properties as a potent antioxidant. There are multiple bioactive properties in GSE, but in particular, its rich content of proanthocyanidins (PACs) plays a role in its theoretical benefit in caries prevention.

PACs have hydrophobic and hydrophilic properties, which enhance their ability to irreversibly bind to a variety of compounds, particularly minerals, proteins, and carbohydrates.

The remineralization effect of GSE appears to be featured. First, it participates in mineral deposition on the superficial layer of the lesion through forming insoluble complexes and combines with calcium to enhance remineralization. Second, GSE may interact with the organic portion of enamel through PA-collagen interaction, thereby stabilizing the exposed collagen matrix.

Proanthocyanidin (PA) has been proved to strengthen collagen-based tissues by increasing collagen cross-links. It is claimed that it can increase collagen synthesis and accelerates the conversion of soluble collagen into insoluble collagen. Proanthocyanidin has proved safe in different clinical applications and has been used as dietary supplements as well.

Dates

Last Verified: 06/30/2020
First Submitted: 04/16/2020
Estimated Enrollment Submitted: 04/20/2020
First Posted: 04/21/2020
Last Update Submitted: 07/12/2020
Last Update Posted: 07/14/2020
Actual Study Start Date: 09/30/2020
Estimated Primary Completion Date: 03/31/2021
Estimated Study Completion Date: 04/30/2021

Condition or disease

Dental Caries

Intervention/treatment

Other: Grape seed extract mouthwash

Other: Sodium fluoride mouthwash

Phase

-

Arm Groups

ArmIntervention/treatment
Experimental: Grape seed extract mouthwash
Grape seed extract mouth wash 15% concentration
Other: Grape seed extract mouthwash
Mouthwash 15% grape seed extract
Active Comparator: Sodium fluoride mouthwash
Sodium fluoride mouthwash 1000 ppm
Other: Sodium fluoride mouthwash
Sodium fluoride mouthwash

Eligibility Criteria

Ages Eligible for Study 13 Years To 13 Years
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

- Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy

- Age range between 13 and 30years.

Exclusion Criteria:

- Severe or active periodontal disease.

- Patients had received therapeutic irradiation to the head and neck region.

- Patients had participated in a clinical trial within 6 months before commencement of this trial.

- Patients unable to return for recall appointments

- Presence of abnormal oral, medical, or mental condition.

- Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.

Outcome

Primary Outcome Measures

1. Remineralization of white spot lesions [Evaluation of tooth surface changes at baseline and at 1, 3 and 6 months after starting treatment .]

changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20)

Secondary Outcome Measures

1. Satisfaction of the patient: questionnaire [After 6 months]

Using binary questionnaire ( Yes/No)

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